Stephanie Macholtz, JD, MBA
About Stephanie Macholtz, JD, MBA
Stephanie Macholtz, JD, MBA, serves as the Vice President of Healthcare Compliance at Organogenesis and has extensive experience in compliance roles across various pharmaceutical companies. She holds degrees from the University of North Carolina at Chapel Hill, Seton Hall University School of Law, and the University of Chicago.
Current Role at Organogenesis
Stephanie Macholtz serves as the Vice President of Healthcare Compliance at Organogenesis, a position she has held since 2022. In this role, she is responsible for overseeing compliance initiatives within the organization, ensuring adherence to regulatory requirements, and fostering a culture of ethical practices. Her expertise in compliance and ethics is critical in navigating complex healthcare regulations and guiding the organization in risk mitigation strategies.
Previous Experience in Compliance
Prior to her current role, Stephanie held various significant positions in compliance across multiple pharmaceutical companies. She worked at Apellis Pharmaceuticals as the Senior Director of Global Compliance and Deputy General Counsel for Clinical Affairs from 2020 to 2021. Before that, she served as the Director of Compliance and Ethics at Alexion Pharmaceuticals from 2018 to 2019 and as Compliance Officer at Biogen from 2013 to 2018. Her extensive experience in these roles has equipped her with a deep understanding of compliance frameworks in the healthcare sector.
Educational Background
Stephanie Macholtz has a robust educational background that supports her expertise in healthcare compliance. She earned a Master of Business Administration (MBA) with a focus on Marketing from the University of North Carolina at Chapel Hill. Additionally, she holds a Juris Doctor (JD) degree from Seton Hall University School of Law, specializing in Health Law. Her undergraduate studies culminated in a Bachelor of Arts in Psychology from the University of Chicago.
Teaching Role at Suffolk University Law School
In addition to her corporate responsibilities, Stephanie serves as Adjunct Faculty at Suffolk University Law School since 2023. In this capacity, she contributes to the education of future legal professionals by sharing her knowledge and experience in healthcare compliance and ethics. Her role in academia complements her practical experience in the field, allowing her to bridge theoretical concepts with real-world applications.
Skills and Expertise in Compliance
Stephanie Macholtz possesses a range of skills and expertise in compliance and ethics. She has demonstrated the ability to lead multi-disciplinary project teams effectively and serves as a trusted partner to global functional leadership. Her experience includes developing compliance and ethics programs that encourage innovation while mitigating risk. Additionally, she has expertise in drafting policies and standard operating procedures (SOPs), which are essential for maintaining compliance within organizations.